510(k) · Cleared
Recalled · Class I · 2026Alaris System with MMS, Model 8XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 303,Inc. · FRN Pump, Infusion
Cleared on Dec 28, 2007 as substantially equivalent to K030459 (Alaris Medical Systems, Inc., 2003) after a 150-day review. Its family tree reaches back 1 generation to 2003. 3 of the 6 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Dec 28, 2007
- Review
- 150 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 5 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030459 (2003). 4 later devices descend from it, 1 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK030459 Medley System with Medication Management System (MMS)Alaris Medical Systems, Inc. · 2003
- This deviceK072105 Alaris System with MMS, Model 8XXXCardinal Health 303,Inc. · 2007
- Descendant · cites it directly · 3 of its ownK133532 Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK211218 BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK243855 BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK210074 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia…Fresenius Kabi AG · 2022
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · cites it directly3descendants
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on1descendant
- K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc. · 2025 · 3 generations on0descendants
- K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030459 | Medley System with Medication Management System (MMS) | Alaris Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K072105 | Alaris System with MMS, Model 8XXX | Cardinal Health 303,Inc. | 2007 | — |
| +1 | K133532 | Alaris System with Guardrails Suite MX | Carefusion 303, Inc. | 2014 | Class I |
| +2 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | 2023 | Class I |
| +3 | K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | 2025 | — |
| +2 | K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link… | Fresenius Kabi AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 1…Pump, Infusion and accessories, FRN (880.5725) PREDICATE DEVICE: Alaris® System with MMS (a.k.a. MedleyTM System with MMS), K030459 DEVICE DESCRIPTION As with the predicate device, the Alaris® System with MMS assists our customers in reducing the number of man… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133532 | Alaris System with Guardrails Suite MX Class I | 2014 | 3 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 11, 2026 | Class II | Z-1645-2026 | Under Investigation by firm | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units |
| Sep 15, 2023 | Class I | Z-0185-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0184-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Sep 15, 2023 | Class I | Z-0186-2024 | Under Investigation by firm | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Jan 24, 2023 | Class II | Z-1192-2023 | Software Design Change | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems.… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
What does this lineage say?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® System with MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Alaris® System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.' All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072105: Alaris System with MMS, Model 8XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072105
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026